Trial of TP Versus TC Regimens for Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00295789
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : September 22, 2016
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Haruhiko Fukuda, Japan Clinical Oncology Group

Brief Summary:
To evaluate the clinical benefits of Paclitaxel plus Carboplatin compared with Paclitaxel plus Cisplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer

Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasms Drug: chemotherapy: Paclitaxel/Cisplatin Drug: chemotherapy: Paclitaxel/Carboplatin Phase 3

Detailed Description:
Prognosis of the advanced, recurrent, or persistent cervical cancer, which is not amenable to curative treatment with surgery and/or radiation therapy, still remains poor. Recently, cisplatin plus paclitaxel for palliative chemotherapy were reported to improve the response rate and progression-free interval compared to cisplatin alone and has been shown as a new appropriate regimen. However, more effective and/or less toxic combinations are needed. Carboplatin as a single agent has less response rate but less overall toxicity than cisplatin. Particularly, because less nephrotoxicity does not require hydration and less neurotoxicity enables 3hrs administration of paclitaxel in the combination, out patient therapy becomes possible and patients' quality of life must improve. Therefore, we planned to evaluate the benefits of less toxicity of the chemotherapy containing paclitaxel and carboplatin, which could reduce the hospitalised days, in comparison with the standard chemotherapy containing paclitaxel and cisplatin. This clinical trial is targeted on the patients in Japan with incurable cervical cancer diagnosed by means of image.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Carboplatin in Stage IVb, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)
Study Start Date : February 2006
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Drug: chemotherapy: Paclitaxel/Cisplatin
Drug: chemotherapy: Paclitaxel/Cisplatin
Drug: chemotherapy: Paclitaxel/Cisplatin
Experimental: 2
Drug: chemotherapy: Paclitaxel/Carboplatin
Drug: chemotherapy: Paclitaxel/Carboplatin
Drug: chemotherapy: Paclitaxel/Carboplatin

Primary Outcome Measures :
  1. overall survival [ Time Frame: During the study conduct ]

Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: During the study conduct ]
  2. response rate [ Time Frame: During the study conduct ]
  3. adverse events [ Time Frame: During the study conduct ]
  4. severe adverse events [ Time Frame: During the study conduct ]
  5. proportion of periods of non-hospitalization to those of the planned treatment [ Time Frame: 18 weeks ]

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. histologically proven uterine cervical cancer
  2. squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix
  3. one of the followings, 1)primary stage Ⅳb cervical cancer, 2)the first relapse or persistent cervical cancer after curative first line treatments, 3)the second relapse or persistent cervical cancer after curative second line treatments including radiation, systemic chemotherapy, hormonal therapy, or vaccination therapy for the first relapse
  4. Patients may have been previously treated with less than 50 Gy of palliative radiation therapy
  5. Patients have received no prior treatment or a certain interval must have elapsed from the last administration of previous treatments including palliative radiation therapy
  6. one of the followings, 1)There is at least one metastatic lesion outside the pelvic cavity except paraaortic LN and/or inguinal LN, 2)There is no metastatic lesion outside the pelvic cavity except paraaortic LN and/or inguinal LN and some of the lesions have been irradiated, 3)All lesions are localized inside the pelvic cavity, and some of them have been irradiated
  7. no prior surgical therapy for metastatic lesions of the lung or inside the pelvic cavity
  8. no bilateral hydronephrosis
  9. no prior chemotherapy including more than two platinum-containing regimens
  10. no prior chemotherapy including taxane
  11. age: 20 to75 years
  12. PS: 0-2
  13. ANC ≧1,500 /mm3, Plt≧10.0×104/mm3, T-bil≦1.5 mg/dl, GOT(AST)≦100IU/l, sCre ≦1.2 mg/dl, Ccr≧50ml/min in using the Cockcroft-Gault equation, and normal ECG
  14. written informed consent

Exclusion Criteria:

  1. patients who have some neurologically functional disorder
  2. symptomatic CNS metastasis
  3. hypersensitive to alcohol
  4. active infection
  5. HBs antigen positive
  6. uncontrollable hypertension
  7. history of myocardiac infarction within six months
  8. unstable angina
  9. uncontrollable diabetes
  10. Patients with a concomitant or prior invasive malignancy (except intramucosal malignancy which are curable with local therapy) who have had any evidence of the disease within the last 5 years
  11. women during pregnancy or breast-feeding
  12. patients with psychiatric illness
  13. patients who have been treated with the systemic steroids medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00295789

Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
Nagoya Medical Center
Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi, Japan, 460-0001
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
Kyushu University Hospital
Fukuoka,Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan, 812-8582
National Kyushu Cancer Center
Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan, 811-1395
Kurume University School of Medicine
Kurume, Asahi-machi, 67, Fukuoka, Japan, 830-0011
Gunma Prefectural Cancer Center
Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan, 373-8550
National Hospital Organization Kure Medical Center Chugoku Cancer Center
Kure,Aoyama-cho,3-1, Hiroshima, Japan, 737-0023
Hokkaido University Hospital
North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan, 060-8648
Sapporo Medical University
S-1,W-16,Chuo-ku,Sapporo, Hokkaido, Japan, 060-8543
Hyogo Medical Center for Adults
Akashi,Kitaouji-cho,13-70, Hyogo, Japan, 673-8558
Institute of Clinical Medicine,Tsukuba University Hospital
Tsukuba,Tennodai,1-1-1, Ibaraki, Japan, 305-8575
Kagoshima City Hospital
Kagoshima,Kajiya-cho,20-17, Kagoshima, Japan, 892-8580
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan, 980-8574
Sinshu University
Matsumoto,Asahi,3-1-1, Nagano, Japan, 390-8621
Nagaoka Red Cross Hospital
Nagaoka,Terashima-cho,297-1, Niigata, Japan, 940-2085
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan, 537-8511
Osaka City General Hospital
Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, Japan, 534-0021
Kinki University School of Medicine
Osaka-Sayama,Ohno-higashi,377-2, Osaka, Japan, 589-8511
Faculty of Medicine, Saga University
Saga,Nabeshima,5-1-1, Saga, Japan, 849-8501
Saitama Medical Center, Saitama Medical School
Kawagoe,Komoda,1981, Saitama, Japan, 350-8550
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, Japan, 362-0806
National Defense Medical College
Tokorozawa,Namiki,3-2, Saitama, Japan, 359-8513
Juntendo University School of Medicine
Bunkyo-ku,Hongo,3-1-3, Tokyo, Japan, 113-0033
The University of Tokyo Hospital
Bunkyo-ku,Hongo,7-3-1, Tokyo, Japan, 113-8655
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, Japan, 135-8550
Jikei University Hospital
Minato-ku,Nishishinbashi,3-25-8, Tokyo, Japan, 105-8461
Tottori University School of Medicine
Yonago,Nishimachi,36-1, Tottori, Japan, 683-8504
Sponsors and Collaborators
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Study Chair: Toshiharu Kamura, MD, PhD Kurume University School of Medicine

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group Identifier: NCT00295789     History of Changes
Other Study ID Numbers: JCOG0505
C000000335 ( Registry Identifier: UMIN-CTR )
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by Haruhiko Fukuda, Japan Clinical Oncology Group:
cervical cancer
palliative chemotherapy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action